Label: DAYTIME NIGHTTIME COLD AND FLU RELIEF MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

  • NDC Code(s): 55319-744-24
  • Packager: Family Dollar (FAMILY WELLNESS)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 20, 2021

If you are a consumer or patient please visit this version.

  • Active ingredients in Daytime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Active ingredients in Nighttime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg

  • Purpose for Daytime

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Purpose for Nighttime

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Uses

    DAYTIME

    • temporarily relieves common cold and flu symptoms
      • cough due to minor throat and bronchial irritation
      • nasal congestion
      • headache
      • minor aches and pains
      • fever
      • sore throat

    NIGHTTIME

    • temporarily relieves common cold and fly symptoms
      • cough due to minor throat and bronchial irritation
      • sore throat
      • headache
      • minor aches and pain
      • fever
      • runny nose and sneezing
  • Warnings

    DAYTIME and NIGHTTIME

    Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    DAYTIME and NIGHTTIME

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    DAYTIME

    • liver disease
    • heart disease
    • diabetes
    • thyroid disease
    • high blood pressure
    • cough that occurs with too much phlegm (mucus)
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

    NIGHTTIME

    • liver disease
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts such as occur with smoking, asthma, chronic bronchitis or emphysema
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    DAYTIME

    • taking the blood thinning drug warfarin

    NIGHTTIME

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product,

    DAYTIME

    do not exceed recommended dosage.

    NIGHTTIME

    • excitability may occur, especially in children
    • avoid alcoholic drinks
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    DAYTIME

    • nervousness, dizziness or sleeplessness occur
    • pain, cough, and nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts

    These could be signs of a serious condition.

    NIGHTTIME

    • pain or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    DAYTIME and NIGHTTIME

    Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    DAYTIME

    • do not take more than directed (see Overdose warning )
    • do not take more than 4 doses in 24 hours 
    • swallow whole; do not crush, chew, or dissolve
    • adults and children 12 years and over: take 2 softgels with water every 4 hours
    • children under 12 years : do not use

    Nighttime:

    • do not take more than directed (see Overdose warning)
    • do not take more than 4 doses in 24 hours
    • swallow whole; do not crush, chew, or disolve
    • adults and children 12 years and over: take 2 softgels with water every 6 hours
    • children under 12 years: do not use
  • Other information

    DAYTIME and NIGHTTIME

    • store between 15°-30°C (59°-86°F)
    • avoid excessive heat
  • Inactive ingredients

    Daytime butylated hydroxyanisole, butylated hydroxytoluene, FD&C red #40*, FD&C yellow #6*, gelatin, glycerin, polyethylene glycol*, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide*, white ink   

    *may contain this ingredient

    Nighttime D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan*, sorbitol

    titanium dioxide*

    *may contain this ingredient

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL® AND NYQUIL® LIQUICAPS®**

    Multi-Symptom

    Cold & Flu Relief

    Acetaminophen - Pain Reliever / Fever Reducer

    Dextromethorphan HBr - Cough Suppressant

    Phenylephrine HCl - Nasal Decongestant

    SOFTGELS

    NIGHTTIME

    Acetaminophen - Pain Reliever / Fever Reducer

    Dextromethorphan HBr - Cough Suppressant

    Doxylamine Succinate - Antihistamine

    SOFTGELS

    When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.

    This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil®, NyQuil®, and LiquiCap® are registered trademarks of The Procter and Gamble Company.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY : MIDWOOD BRANDS, LLC

    10611 MONROE RD., MATTHEWS, NC 28105

  • Product Label

    Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCI 5 mg, Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Doxylamine Succinate 6.25 mg

    FAMILY WELLNESS DayTime NightTime Cold & Flu Relief

  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME COLD AND FLU RELIEF  MULTI-SYMPTOM
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-744
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-744-241 in 1 KIT; Type 0: Not a Combination Product04/30/201807/26/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 18 BLISTER PACK
    Part 216 BLISTER PACK 16 
    Part 1 of 2
    NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P30;94A;P120;AP017
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/30/201807/26/2024
    Part 2 of 2
    DAYTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, phenylephrine hci capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P19;95A;512;AP016
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/30/201807/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/30/201807/26/2024
    Labeler - Family Dollar (FAMILY WELLNESS) (024472631)